Robust and durable tumor response observed at 2‑year follow‑up with ROMVIMZA¹*

Vimseltinib (ROMVIMZA®) is a Category 1 Preferred systemic therapy option for patients with TGCT²

Tumor response by RECIST^1,3

Tumor response (%); At 6 months; Placebo n=40 (95% CI 0, 9) equals 0%; ROMVIMZA® (vimseltinib) n=83 (95% CI: 29, 51) equals 40% n=33; 5% CR n=4; 35% PR n=29; At greater than or equal to 2 years; ROMVIMZA® n=83 (95% CI: 37, 59) equals 48% n=40; 23% CR n=19 (response deepened over the greater than or equal to 2 years); 25% PR n=21; Chance to be tumor-free: nearly 1 in 4 patients achieved a complete response at 2 years

The ORR by RECIST at ≥2 years for patients in the crossover group was 54% (19/35)
(11% CR; 43% PR; 95% CI: 37, 71)

Tumor response by tumor volume score^1,3,4

Tumor response (%); At 6 months; Placebo n=40 (95% CI 0, 9) equals 0%; ROMVIMZA® (vimseltinib) n=83 (95% CI: 56, 77) equals 67% n=56; 5% CR n=4; 63% PR n=52; At greater than or equal to 2 years; ROMVIMZA® n=83 (95% CI: 71,89) equals 81% n=67; 24% CR n=20; 57% PR n=47

The ORR by TVS at ≥2 years for patients in the crossover group was 71% (25/35)
(11% CR; 60% PR; 95% CI: 54, 85)

Duration of response by RECIST^1,5

≥6 months: 85%
≥9 months: 79%
≥12 months: 73%

At ≥2 years, median DOR was still not reached for both groups
- ROMVIMZA (range, 0.03+ to 30.9+ months)
- Crossover (range, 0.03+ to 25.4+ months)

Open‑label extension data should be considered descriptive in nature, therefore interpret these data with caution

*Long‑term results from MOTION with ≥2 years of follow‑up on study: Median (range) treatment duration was 23.6 months (2‑36) for patients randomized to ROMVIMZA and 19.1 months (1‑30) for those who crossed over to ROMVIMZA.¹

^†Percentages may not add up to ORR due to rounding.

“+” indicates that the patient’s response was ongoing at the last assessment as of the data cutoff date (February 22, 2025).¹

CI=confidence interval; CR=complete response; NCCN=National Comprehensive Cancer Network^® (NCCN^®); ORR=objective response rate; PR=partial response; RECIST v1.1=Response Evaluation Criteria in Solid Tumors version 1.1; ROM=range of motion; TGCT=tenosynovial giant cell tumor; TVS=tumor volume score.

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References: 1. Bauer S, Bhadri V, Gelderblom H, et al. Long-term efficacy and safety of vimseltinib in patients with tenosynovial giant cell tumor: 2-year results from the MOTION phase 3 trial. Poster presented at the European Society for Medical Oncology (ESMO) Congress 2025, October 17–21, Berlin, Germany. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Soft Tissue Sarcoma V.5.2026 © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed July 23, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 3. ROMVIMZA [package insert]. Waltham, MA: Deciphera Pharmaceuticals, LLC. 4. Gelderblom H, Bhadri V, Stacchiotti S, et al. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403(10445):2709-2719. 5. Data on file. Deciphera Pharmaceuticals, LLC; 2026.

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications and Usage

ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity:

Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R. Serious and fatal liver injury have not been observed with ROMVIMZA.
Elevated AST and ALT can occur with ROMVIMZA.
Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.
Monitor liver function tests prior to initiation of ROMVIMZA, twice a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity.

Embryo-Fetal Toxicity:

ROMVIMZA may cause fetal harm when administered to pregnant women. Advise pregnant women on the potential risk to the fetus.
Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF):

ROMVIMZA 20 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. FD&C Yellow No. 5 (tartrazine) sensitivity is frequently seen in patients who also have aspirin sensitivity.
Advise patients that ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No. 6 (Sunset Yellow FCF), which may cause allergic reactions.

Increased Creatinine without Affecting Renal Function:

Increases in serum creatinine can occur with the use of ROMVIMZA. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation. During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.

Adverse Reactions:

The most common (≥20%) adverse reactions, including laboratory abnormalities that occurred in patients receiving ROMVIMZA were increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.

Drug Interactions:

P-glycoprotein (P-gp) substrates: Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates.
Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use of ROMVIMZA with BCRP substrates.
Organic Cation Transporter 2 (OCT2) substrates: Avoid concomitant use of ROMVIMZA with OCT2 substrates.
Concomitant use of vimseltinib with P-gp substrates, BCRP substrates or OCT2 substrates may increase exposure of these substrates.

Lactation: Advise females not to breastfeed during treatment with ROMVIMZA.

Please click for the full Prescribing Information.

Indications and Usage

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications and Usage

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity:

Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R. Serious and fatal liver injury have not been observed with ROMVIMZA.
Elevated AST and ALT can occur with ROMVIMZA.
Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.
Monitor liver function tests prior to initiation of ROMVIMZA, twice a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity.

Embryo-Fetal Toxicity:

ROMVIMZA may cause fetal harm when administered to pregnant women. Advise pregnant women on the potential risk to the fetus.
Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF):

ROMVIMZA 20 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. FD&C Yellow No. 5 (tartrazine) sensitivity is frequently seen in patients who also have aspirin sensitivity.
Advise patients that ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No. 6 (Sunset Yellow FCF), which may cause allergic reactions.

Increased Creatinine without Affecting Renal Function:

Increases in serum creatinine can occur with the use of ROMVIMZA. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation. During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.

Adverse Reactions:

Drug Interactions:

P-glycoprotein (P-gp) substrates: Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates.
Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use of ROMVIMZA with BCRP substrates.
Organic Cation Transporter 2 (OCT2) substrates: Avoid concomitant use of ROMVIMZA with OCT2 substrates.
Concomitant use of vimseltinib with P-gp substrates, BCRP substrates or OCT2 substrates may increase exposure of these substrates.

Lactation: Advise females not to breastfeed during treatment with ROMVIMZA.

Please click for the full Prescribing Information.

Robust and durable tumor response observed at 2‑year follow‑up with ROMVIMZA¹*

Week 25: Best percentage change in target lesions
in patients receiving ROMVIMZA⁴

Analysis limitations for waterfall plot

Help your patients get started on ROMVIMZA

WARNINGS AND PRECAUTIONS

Week 25: Best percentage change in target lesions in patients receiving ROMVIMZA4

Analysis limitations for waterfall plot

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Week 25: Best percentage change in target lesions
in patients receiving ROMVIMZA⁴

Help your patients get started on ROMVIMZA